Systems and methods for percutaneous spinal fusion

ABSTRACT

A system for percutaneous spinal fusion may include two spaced apart blades connected together by a coupling such that the blades define a percutaneous pathway from a skin incision to an implanted pedicle fastener. The coupling may be c-shaped and may have at least one flexible tab for engaging one or more holes along the length of the blades. If one of the blades becomes disconnected from the pedicle fastener, a supplemental access device may be provided comprising a tubular body having a channel therein for receiving the other of the blades. If both of the blades become disconnected, a supplemental access device may be provided comprising a gripping member received within a locking member. The gripping member may have two legs engageable with the pedicle fastener, and the locking member may move along the gripping member to prevent the legs from disengaging the pedicle fastener.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of the filing date of U.S.Provisional Application No. 61/783,098 filed Mar. 14, 2013, thedisclosure of which is hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates to systems and methods for the insertionof spinal fixation rods, or simply spinal rods or fixation rods, and inparticular, to systems and methods for percutaneously guiding spinalfixation rods to a target location adjacent the spinal column.

Pedicle screw fixation systems have been in use for decades in order tofuse adjacent vertebral segments to improve spinal stability or correctcertain spinal deformities. Older approaches for inserting thesefixation systems involved open procedures, in which relatively largeskin incisions were created to expose a substantial portion of thepatient's spinal column, in order to allow for insertion of the pediclescrews and manipulation of spinal rods through openings in pediclescrews, such openings typically being in heads of the screws.

Over time, less invasive approaches have been developed. Typically, insuch approaches, pedicle screws are inserted into the pedicles ofselected vertebrae of a patient's spine through individual percutaneousincisions corresponding to the pedicle screws. Fixation or fusion rodsare then inserted into the body through one of those incisions orthrough an additional incision adjacent to the most cephalad or caudalpedicle screw, and the rod is positioned through openings in the headsof the pedicle screws to fix the relative positions of the pediclescrews through which the rod is inserted. In some such minimallyinvasive procedures, a percutaneous access device (e.g., a cannula orportal) is connected to each of the pedicle screws and extends throughthe respective percutaneous incision. Such percutaneous access devicesprovide a pathway through the tissue from each incision to therespective pedicle screw, in order to aid in the insertion of a spinalrod. Examples of such percutaneous access devices are described incommonly-assigned U.S. Pat. No. 7,955,355 (“the '355 patent”) and U.S.Pat. No. 8,002,798 (“the '798 patent”), the entireties of which arehereby incorporated by reference herein as if fully set forth herein.

One example of a commercially used minimally invasive spinal fusionsystem is the MANTIS® Spinal System developed by Stryker Corporation,the assignee of the present application, and exemplified by the spinalfixation system shown in FIGS. 1A and 1B. As shown in those figures,blades 2 are connected to opposing sides of the heads 3 of pediclescrews implanted in respective vertebrae, such that the blades 2 extendposteriorly through respective incisions in the patient's skin anddefine pathways extending between each incision and the respectivepedicle screw. In certain systems, the blades 2 may be separately formedfrom and detachably connectable to the pedicle screw heads 3, and, inother systems, the blades may be integrally formed with the pediclescrew heads 3 to form monolithic blade-screws. In the case of integrallyformed blade-screws, the blades 2 may be connected to the pedicle screwheads 3 by frangible portions (e.g., reduced thickness portions, whichmay be defined by grooves formed in either or both of the interior andexterior surfaces of the blade-screws at the junction between the bladesand the pedicle screw heads). Such frangible portions provide a locationfor the blades to be broken away from the pedicle screw heads whendesired. With either form of the blades, a rigid ring 7 may be placedover and slid along each of the blades 2 until the rigid ring 7 abutsthe skin of the patient. In this manner, the ring 7 may stabilize thespinal insertion system with respect to the skin and also providerigidity to the spinal rod insertion system by maintaining the relativepositioning of the blades 2 and resisting their disconnection from thepedicle screw heads 3. Similar blade and abutment ring structures aredescribed in the '798 patent.

In the minimally invasive approach illustrated in FIGS. 1A and 1B, a rodinsertion tool 4 is used to insert a fixation rod 5 into the bodybetween the blades 2, which act to provide percutaneous pathways andhelp to guide the movement of the rod 5 to the desired positionconnecting the pedicle screw heads 3. Following insertion of the rod 5,the blades 2 are intentionally disconnected from the pedicle screw heads3 and removed from the patient.

When using a blade-screw having blades integrally formed with a pediclescrew head, one or both of the blades can be broken at the respectiveone or both of the frangible connections between the blades and thescrew head during insertion and manipulation of the rod 5, and evenduring insertion of the blade-screw. In such instances, the brokenblade-screw needs to be replaced in order to provide a guide in which toinsert the fixation rod 5, requiring dilation to retract theblade-screw. Thus, there is a need for systems and methods to guide thefixation rod without dilation and without requiring the use of aseparate guide.

BRIEF SUMMARY OF THE INVENTION

One aspect of the present invention provides a method for restoring apercutaneous pathway to a pedicle fastener connected to a vertebra of apatient. The method according to this aspect of the invention desirablyincludes inserting a percutaneous access device into a body of a patientthrough an incision, such that the percutaneous access device desirablyprovides a first pathway extending from the incision to a head of apedicle fastener connected to a vertebra of the patient. The method mayalso include removing at least a portion of the percutaneous accessdevice. The method desirably further includes attaching a supplementalaccess device to the head of the pedicle fastener. According to thisaspect of the invention, the supplemental access device desirablyprovides a second pathway extending from the incision to the head of thepedicle fastener.

According to another aspect of the invention, the step of removing atleast a portion of the percutaneous access device may cause thecross-sectional area of the first pathway to be substantially reduced oreliminated. According to this aspect of the invention, a cross-sectionalarea of the second pathway transverse to a longitudinal axis of thesupplemental access device preferably has substantially the same size asa cross-sectional area of the first pathway transverse to a longitudinalaxis of the percutaneous access device.

According to another aspect of the invention, the percutaneous accessdevice preferably includes first and second slots diametrically opposedto one another so that a fixation rod may pass through the slots along adirection transverse to a longitudinal axis of the percutaneous accessdevice. According to yet another aspect of the invention, thesupplemental access device preferably includes first and second slotsdiametrically opposed to one another so that a fixation rod may passthrough the slots along a direction transverse to a longitudinal axis ofthe supplemental access device. According to yet a further aspect of theinvention, the method preferably includes inserting the fixation rodinto the body of the patient along at least a portion of the secondpathway provided by the supplemental access device, such that thefixation rod passes through at least one of the slots of thesupplemental access device.

According to another aspect of the invention, the percutaneous accessdevice preferably includes a first and second blade spaced apart fromone another and extending substantially parallel to one another whenconnected to the head of the pedicle fastener. According to this aspectof the invention, the first and second slots of the percutaneous accessdevice are preferably defined by the first and second blades, the slotsextending along the longitudinal axis of the percutaneous access devicebetween the first and second blades.

According to another aspect of the invention, the first and secondblades are preferably each integrally formed with the head of thepedicle fastener and connected thereto by a frangible portion.

According to another aspect of the invention, the step of removing atleast a portion of the percutaneous access device may include removingthe first blade from the head of the pedicle fastener. According to yetanother aspect of the invention, the step of attaching the supplementalaccess device to the head of the pedicle fastener preferably includesreceiving the second blade in a receiving structure of the supplementalaccess device.

According to another aspect of the invention, the step of removing atleast a portion of the percutaneous access device may include removingboth of the first and second blades from the head of the pediclefastener. According to yet another aspect of the invention, the step ofattaching the supplemental access device to the head of the pediclefastener preferably includes engaging a gripping member and a lockingmember of the supplemental access device with the head of the pediclefastener. According to this aspect of the invention, the locking memberis preferably adapted to prevent disengagement between the grippingmember and the head of the pedicle fastener.

Further aspects of the invention provide an access device forpercutaneously accessing a pedicle fastener connected to a vertebra of apatient. The access device according to this aspect of the inventiondesirably includes an elongate gripping member and an elongate lockingmember. The elongate gripping member desirably has a body portion andalso has first and second legs. Each of the legs desirably has aproximal portion connected to the body portion and a distal portion forengagement with a head of a pedicle fastener. The distal portion of eachof the first and second legs desirably includes a first prong and asecond prong. The first and second prongs desirably have a longitudinalslot between them which permits the first and second prongs to deflectrelative to each other. The distal portions of the first and second legsare desirably deflectable away from one another so as to engage anddisengage the head of the pedicle fastener. According to this aspect ofthe invention, the elongate member is connected to and movable relativeto the gripping member between a retracted position and a lockedposition. The locking member preferably prevents the first and secondlegs of the gripping member from deflecting away from one another whenthe locking member is in the locked position.

According to another aspect of the invention, the locking memberpreferably includes at least one projection arranged to be receivedwithin the slot between the first and second prongs of either the firstor second legs of the gripping member. According to this aspect of theinvention, movement of the locking member to the retracted positionpreferably causes the projection to move within the slot so as todeflect the first and second prongs away from one another.

According to another aspect of the invention, the locking memberpreferably includes at least one projection arranged to be receivedwithin a recess in the gripping member. According to this aspect of theinvention, movement of the locking member to the locked positionpreferably causes the projection of the locking member to move into therecess of the gripping member so as to restrain movement of the firstand second prongs away from one another.

According to another aspect of the invention, the gripping member ispreferably received within the locking member. The locking memberpreferably has a generally curved interior surface shaped tosubstantially match an exterior surface of the gripping member. Thelocking member also preferably includes a substantially flat exteriorsurface.

Yet further aspects of the invention provide an access device forpercutaneously accessing a fixed pedicle fastener, which pediclefastener preferably has a head and a blade. The access device accordingto this aspect of the invention desirably includes an elongate tubularbody defining a central bore therethrough and a groove spaced from thecentral bore. The groove is desirably dimensioned to receive the bladetherethrough. A distal end of the tubular body is desirably adapted forengagement with the head of the fastener.

Yet further aspects of the invention provide a retractor for insertingor positioning a fixation rod in a pedicle fastener. The pediclefastener preferably has a head and a blade extending therefrom. Theblade preferably has a plurality of holes in linear alignment along itsproximal portion, and the head preferably has a groove therein. Theretractor according to this aspect of the invention desirably includes abody, a first leg extending from the body, and a second leg extendingfrom the body. The body desirably defines a central bore having alongitudinal axis therethrough. The body desirably has grooves forgripping around a circumference thereof. The body desirably has at leastone deflectable arm formed through a thickness of the body. Thedeflectable arm is desirably a partial cutout of the thickness of thebody such that the arm is predisposed to bending in a lateral direction.The arm desirably has an inwardly extending boss. The first legdesirably has a first prong on its distal end for insertion into thegroove of the head of the pedicle fastener. The first leg desirably hasa plurality of holes in linear alignment along its distal portion. Thesecond leg desirably has a second prong on its distal end for insertioninto the groove of the head of the pedicle fastener. According to anaspect of the invention, the body preferably includes a groove thereinoffset from an inner perimeter of the central bore. The groove isdesirably dimensioned to receive the blade of the pedicle fastener suchthat the blade is not removable from the groove in a lateral direction.The groove desirably shares inner edges with the central bore.

Yet further aspects of the invention provide a system for inserting orpositioning a fixation rod in a pedicle fastener. The pedicle fastenerpreferably has a head and a blade extending therefrom. The bladepreferably has a plurality of holes in linear alignment along itsproximal portion, and the head preferably has a groove therein. Thesystem according to this aspect of the invention desirably includes apersuader and also desirably includes a retractor in accordance withaspects of the invention described above. The persuader desirablyincludes a body having an inner perimeter approximately equal to anouter perimeter of the retractor such that the persuader is slidablealong the length of the retractor. The body of the persuader desirablyhas a viewing window for viewing the relative positions of the retractorand the persuader during placement of the persuader. The inner perimeterof the persuader is desirably dimensioned to confine the retractor whenthe blade of the fastener is received in the retractor. The body of thepersuader desirably includes one of a plurality of protrusions and aplurality of holes in linear alignment for engagement with a pluralityof holes along a distal portion of the first leg of the retractor. Adistal surface of the body of the persuader is desirably adapted forexerting a force against the fixation rod to cause the fixation rod tomove in a distal direction. The persuader desirably also includes ahollow flange. The hollow flange preferably extends at an oblique angleto a longitudinal axis of the body. The persuader desirably alsoincludes a handle assembly. The handle assembly preferably extends at anoblique angle to the longitudinal axis of the body. The handle assemblydesirably has a connecting rod attached to the hollow flange by afastener, and the connecting rod desirably has a handle extendingtherefrom.

Yet further aspects of the invention provide a method for inserting orpositioning a fixation rod in a pedicle fastener. The pedicle fastenerpreferably has a head and a blade extending therefrom. The bladepreferably has a plurality of holes in linear alignment along itsproximal portion, and the head preferably has a groove therein. Themethod according to this aspect of the invention desirably includesplacing a retractor in accordance with aspects of the inventiondescribed above over the blade of the fastener. The method desirablyfurther includes sliding the retractor such that the first and secondprongs of the retractor are inserted into the groove of the head of thepedicle fastener. The method desirably further includes placing apersuader in accordance with aspects of the invention described aboveover at least the first and second prongs of the retractor. The methoddesirably further includes sliding the persuader along the length of theretractor to exert a force against the fixation rod to cause thefixation rod to move in a distal direction.

Yet further aspects of the invention provide a coupling for receivingand maintaining positioning of adjacent blades of a pedicle fastener.The blades preferably have at least one hole. The coupling according tothis aspect of the invention desirably includes a tubular body having athickness and defining a central bore therethrough. The tubular bodydesirably includes at least two spaced apart channels therein. Eachchannel is desirably dimensioned to receive an adjacent bladetherethrough. The tubular body desirably includes at least one tabformed through the thickness. The tab is desirably deflectable into thecentral bore for engagement with at least one of the holes of theadjacent blades.

Yet further aspects of the invention provide a coupling for receivingand maintaining positioning of adjacent blades of a pedicle fastener.The coupling according to this aspect of the invention desirably hasinner and outer perimeters spaced apart by a thickness and extendingalong a length from a proximal to a distal end thereof. The innerperimeter desirably defines a central hole having a longitudinal axiscentrally located therethrough. The coupling desirably defines a gapextending through its thickness and along its entire length. Thecoupling desirably further includes a pair of opposing channelsextending along the longitudinal axis. Each of the channels is desirablydefined by opposing protrusions on both the proximal and distal ends ofthe coupling. Each of the channels desirably extends from the innerperimeter into the thickness, and each of the channels is desirablydimensioned to receive one of the adjacent blades of the pediclefastener such that the blade is not removable from the correspondingchannel in a lateral direction. The coupling desirably further includesopposing deflectable tabs formed in the thickness and located withincorresponding opposing slots, such that the tabs are predisposed tobending in the lateral direction. Each of the tabs desirably has aninwardly extending protuberance. The coupling desirably further includesa recess extending from the proximal end through the thickness. Therecess is desirably dimensioned to receive a fixation rod. The recess isdesirably located opposite the gap in the coupling. The couplingdesirably further includes flanges at both the proximal and distal ends.The flanges desirably have a wider thickness than a portion of thecoupling between the flanges.

Yet further aspects of the invention provide a coupling system forreceiving and maintaining positioning of adjacent blades of adjacentpedicle fasteners. The coupling system according to this aspect of theinvention desirably includes a pair of couplings in accordance withaspects of the invention described above. Each of the couplings isdesirably placed on the adjacent blades of one of the adjacent pediclefasteners. The coupling system desirably further includes a fixation rodplaced within each of the recesses of the pair of couplings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B show perspective views of a spinal fixation systemduring and after insertion of a fixation rod thereof, respectively, asknown in the prior art.

FIG. 2A shows a perspective view of an arrangement of a coupling inaccordance with an embodiment of the present invention.

FIG. 2B shows a perspective view of an assembly of a pedicle blade-screwand a coupling in accordance with an embodiment of the presentinvention.

FIG. 3 shows a perspective view of a pedicle blade-screw having a singleblade.

FIG. 4 shows a perspective view of a blade rescue system including thepedicle blade-screw of FIG. 3 in accordance with an embodiment of thepresent invention.

FIG. 5 shows a perspective view of a blade rescue retractor of the bladerescue system of FIG. 4 being placed over the blade-screw of FIG. 3.

FIGS. 6A and 6B show perspective and cross-sectional elevation views ofthe retractor of the blade rescue system of FIG. 4 assembled to theblade-screw of the blade rescue system of FIG. 4.

FIG. 7 shows a perspective view of a persuader of the blade rescuesystem of FIG. 4 placed over the blade-screw of FIG. 3.

FIGS. 8A and 8B show enlarged perspective and cross-sectional elevationviews of a distal portion of the blade rescue system of FIG. 4.

FIG. 9 illustrates the use of a blade rescue retractor over ablade-screw having a single blade during insertion of a spinal fixationrod during a spinal surgery in accordance with an embodiment of thepresent invention.

FIG. 10 illustrates persuasion of the spinal rod through the bladerescue system used during the spinal surgery illustrated in FIG. 9.

FIG. 11 illustrates a perspective view of a blade rescue retractorengaging a pedicle screw head in accordance with another embodiment ofthe present invention.

FIG. 12 illustrates a perspective, exploded view of the components ofthe blade rescue retractor of FIG. 11.

FIG. 13 illustrates a perspective view of a gripping member of the bladerescue retractor of FIG. 11.

FIG. 13A illustrates an enlarged perspective view of section A in FIG.13.

FIG. 13B illustrates a partial perspective view of the blade retractorsystem of FIG. 11.

FIG. 14 illustrates a partial sectional view of the gripping member ofFIG. 13 moving into engagement with a pedicle screw head.

FIG. 15 illustrates a perspective view of a component of a lockingmember of the blade rescue retractor of FIG. 11.

FIG. 16A illustrates a perspective view of another component of alocking member of the blade rescue retractor of FIG. 11.

FIG. 16B illustrates a sectional view of the component FIG. 16B.

FIGS. 17A-D illustrate perspective views of portions of a method ofusing the blade rescue retractor of FIG. 11.

FIG. 18 illustrates a perspective view of a gripping member of a bladerescue retractor in accordance with another embodiment of the presentinvention.

FIG. 19 illustrates a perspective view of a locking member of a bladerescue retractor in accordance with another embodiment of the presentinvention.

DETAILED DESCRIPTION

Where reference is made herein to directional terms such as “proximal,”“proximal most,” “distal,” and “distal most,” it is to be understoodthat “proximal” and “proximal most” refer to locations closer to a useror operator of the device or method being described and that “distal”and “distal most” refer to locations further from a user or operator ofthe device or method being described.

Referring to FIGS. 2A and 2B, in accordance with one embodiment, acoupling 17 may include inner and outer perimeters 22, 24 spaced fromone another by a thickness of the coupling 17 in which the innerperimeter 22 defines a central opening along a longitudinal axis of thecoupling 17. As shown, the coupling 17 may have ends 26, 28 spaced fromone another such that the ends 26, 28 define a gap passing through theinner and outer perimeters 22, 24 and the thickness therebetween. Asshown, the coupling 17 may be in the form of a “c-ring,” although othershapes, such as but not limited to a square having a gap through one ofthe sides, may be used.

The coupling 17 may be placed over and assembled with an integrallyformed blade-screw 11, as shown in FIG. 2B, or in some arrangements, ablade-screw that may be an assembly of a blade and a pedicle screwattached by a fastener, through a snapped connection, or by otherattachment mechanisms known to those of ordinary skill in the art. Toattach the coupling 17 to the blade-screw 11, the coupling 17 mayinclude opposing channels 32, 34 set in or offset from the innerperimeter 22 that may receive the opposing blades 12 therethrough, asshown in FIGS. 2A and 2B. In this manner, the coupling 17 may maintainseparation between the opposing blades 12 to stabilize and providestiffness to the blades 12 during one or both of insertion of the bladescrew 1 into the body and insertion of the fixation rod 5 into theblade-screw 1, and to provide the surgeon or other qualified user withdirect visualization of the fixation rod 5 during insertion thereof.Moreover, the opposing channels 32, 34 may be dimensioned to align andorient the blades 12 of the blade-screw 11 at a particular angularposition relative to each other.

As shown, in some arrangements, each of the channels 32, 34 may bedefined by protrusions 37, 38 that may form spaced apart wallsseparating the inner perimeter 22 from the channels 32, 34. In thismanner, such walls may have edges common to both the inner perimeter 22and the respective opposing channels 32, 34. Such protrusions 37, 38desirably secure the blades 12 within the channels 32, 34 by preventingthe blades 12 from moving inwardly towards each other. In somearrangements, to secure one of the blades in a channel, at least oneprotrusion may be located at the proximal end and at least oneprotrusion may be located at a distal end on one side of the coupling.

As shown, in some arrangements, the coupling 17 may include either orboth of upper and lower flanges 41, 42 that may extend outwardly awayfrom the longitudinal axis of the coupling 17 to stiffen the coupling 17and also to provide surfaces against which a user may push to ease thesliding of the coupling 17 along the blades 12. A flexible tab 35, whichmay include a boss or protuberance 36 extending inwardly from the innerperimeter 24 towards the longitudinal axis may extend around a portionof the coupling 17. As shown, the tab 35 may be formed by making aU-shaped cut through the thickness of the coupling 17 between the innerand outer perimeters 22, 24. As illustrated in FIG. 2B, the blades 12may include one or more holes 8 along a length of the blades 12 whichpass through a thickness of the blades 12 and which may be sized toreceive the boss 36 of the flexible tab 35 of the coupling 17. In somearrangements, the coupling 17 may be flexible such that the ends 26, 28are separated a greater distance when the coupling 17 is placed over theopposing blades 12 than when the coupling 17 is not in use. In thismanner, when the coupling 17 is placed over the opposing blades 12, eachof the tabs 35 may be predisposed to compress against the respectiveblades 12 such that the respective bosses 36 of the tabs 35 protrudeslightly into the holes 8 as the bosses 36 passes over the holes 8. Inthis manner, the coupling 17 provides feedback to the user that thecoupling 17 is in a predetermined location.

In some arrangements, at least a pair, and desirably all, of couplings17 forming a set of couplings may each include a recess 39, in whicheach such recess 39 may be located opposite the respective gaps definedby the ends 26 and 28 of the respective couplings 17. In sucharrangements, each of the holes 8 of the opposing blades 12 engaged byeach of the set of couplings 17 may be located at the same relativeheights along the respective blades 12. In this manner, when eachblade-screw 11 of a set of blade-screws are inserted to a predeterminedposition in the vertebrae of a patient and the tabs 35 of the set ofcouplings 17 are placed such that the bosses 36 of the tabs 35 arealigned to protrude into the holes 8 at the same relative positionsalong the blades 12 of the respective blade-screws 11, the recesses 39of the couplings 17 will be spaced above the respective pedicle screwheads (not shown) of the blade-screws 11 by the same height. Therefore,the relative positioning of the recesses 39 will desirably mimic therelative positioning of the rod receiving surfaces 55 (see FIG. 3 forexample) in the pedicle screw heads of the blade-screws 11 into whichthe fixation rod 5 is to be placed. The distances between the recesses39 may thus be used to help determine an appropriate length for thefixation rod 5. Additionally, the recesses 39 provide an extracorporealtemplate for contouring or selecting a fixation rod 5 to be implanted inthe same manner as the rod configuration systems disclosed in commonlyowned U.S. Pat. No. 8,177,817 (“the '817 patent”) and U.S. PatentApplication Publication No. 2007/0233079 (“the '079 Publication”), theentireties of which are hereby incorporated by reference herein as iffully set forth herein. For example, the recesses 39 are desirablyshaped to receive and support an appropriately shaped fixation rod 5 ina position such that the fixation rod 5 simultaneously extends throughthe various recesses 39. The fixation rod 5 may thus be contoured (e.g.,with a French bender), selected from a kit of pre-shaped rods, or customfabricated (e.g, by a CNC procedure) such that the rod 5 provides anoptimal fit within the recesses 39, and thus, in turn, within the rodreceiving surfaces 55 of the pedicle screw heads of the blade-screws 11.In another arrangement, one or more bridges (not shown), as described inthe '817 patent and the '079 Publication, may be used to couple togethertwo or more of the blade-screws 11 and constrain their relativeorientations (e.g., such that they are substantially parallel to oneanother).

Referring now to FIG. 3, a blade-screw 51 may include only a singleblade 52 extending from a pedicle screw head 53 in contrast to theblade-screws 1, 11 previously described herein, which may be due to apreviously attached opposing blade having become disconnected from thepedicle screw head 53. For example, the previously attached opposingblade may have been unintentionally broken off at the frangible portion16, or the blade may have been intentionally broken off before it wasdetermined that further revision may be necessary. In such aconfiguration, the blade-screw 51 may be unable to provide apercutaneous pathway for the insertion of a fixation rod such as the rodinsertion tool 4 previously described herein.

As shown in FIG. 4, a blade rescue system 10 may be utilized to insert afixation rod 105 by using the single blade 52 of the blade-screw 51.Along with the blade-screw 51, the blade rescue system 10 may include ablade rescue retractor 60 that may be placed over and engaged with ablade-screw 51. A persuader 80 having a handle 95 extending therefromdescribed further herein may be placed over and engaged with theretractor 60. In this configuration, a blocker inserter assembly 100 maybe inserted along a central longitudinal axis within the assembly of theblade-screw 51, the retractor 60, and the persuader 80, into engagementwith the blade-screw 51 in order to guide and persuade the insertion ofthe fixation rod 105.

As illustrated in FIGS. 5, 6A, and 6B, the retractor 60 may include abody 65 having opposing first and second legs 64, 66 extending in adistal direction therefrom. The retractor 60 may have a generallytubular shape, and the legs 64, 66 may define diametrically opposedslots 67 extending proximally from the distal end of the retractor 60.Such slots 67 desirably provide a space through which a fixation rod maypass, and, in some instances, provide a viewing window between the legs64, 66. The retractor 60 may be placed over the blade-screw 51 such thatthe blade-screw 51 is received within an inner perimeter 77 of theretractor 60. To facilitate such placement, a gripping aid 61, such asparallel grooves at a proximal portion of and perpendicular to thecentral axis of the retractor 60, knurling (not shown), or otherfriction-inducing features may be added to the retractor 60. As shown,in some arrangements, the inner perimeter 77 of the retractor 60 mayinclude an inner diameter 78 defining a central bore having alongitudinal axis which may receive the blocker inserter assembly 100.In some arrangements, a groove 79 may be offset from the inner diameter78 along a length thereof. In this manner, the retractor 60 may beplaced over the blade-screw 51 such that the single blade 52 of theblade-screw 51 may slide within and along a length of the groove 79. Insome arrangements, the groove 79 may have a shape similar to the grooves32, 34 of the coupling 17 as described above. Furthermore, in somearrangements, the groove 79 may interface with the inner perimeter 77 ina manner similar to the interfaces of the grooves 32, 34 and the innerperimeter 22 of the coupling 17 (e.g., having protrusions to secure theblade 52 within the groove).

As best shown in FIG. 6B, the first leg 64 may extend over the blade 52.As further shown, in some arrangements, the first leg 64 may have athickness such that a total thickness of the first leg 64 and the blade52 is approximately, i.e., within at least 10% and more preferably,within 1%, and still more preferably within 0.1%, of the thickness ofthe second leg 66. In this manner, the first leg 64 of the retractor 60may provide sufficient, and, in some arrangements, balanced rigidity toprohibit bending of the first leg 64 during insertion of a fixation rodwhile extending only minimally beyond the outer width dimension of theblade-screw 51, consistent with the desire that the pathway through thetissue be as minimally invasive as possible.

Referring again to FIG. 5 as well as to FIGS. 6A and 6B, the retractor60 may include an arm 62 extending from the body 65 thereof. As shown,the arm 62 may extend from or be formed by a cutout of the body 65. Asfurther shown, a boss 63 may extend inwardly from the inner diameter 77of the retractor 60. In this manner, when the retractor 60 is placedover the blade 52 of the blade-screw 51, the boss 63, or in somearrangements, a plurality of bosses, may be predisposed to extend intoone or more recesses or holes 54 of the blade 52. The holes 54 may havea nominal diameter of 2 mm, although the holes 54 may have a differentdiameter. In some arrangements, the boss 63 may have a diameter slightlyless than the diameter of the holes 54, while in other arrangements, theboss 63 may have a diameter slightly greater than the diameter of theholes 63 such that an interference fit may be established upon insertionof the boss 63 into one of the holes 54. In configurations having aplurality of holes 54, such holes may be placed in linear alignmentalong a length of the blade 52 such that the retractor 60 may bemaintained at various positions relative to the blade-screw 51. Asshown, in some arrangements, the corresponding hole or holes 54 of theblade-screw 51 may be placed near a proximal end of the retractor 60.

As best shown in FIG. 6B, in some arrangements, the first and secondlegs 64, 66 of the retractor 60 may include respective prongs 68, 69 atthe distal end of the retractor 60. The pedicle screw head 53 of theblade-screw 51 may include a corresponding groove 56 around at least aportion of the perimeter thereof for receiving the prongs 68, 69. Asfurther shown, in some arrangements, the first and second legs 64, 66 ofthe retractor 60 may include grooves 71, 72. In such arrangements, thehead 53 of the blade-screw 51 may include a protrusion 57 around atleast a portion of the perimeter thereof that may be inserted into thegrooves 71, 72 of the retractor 60. In this manner, the retractor 60 maybe placed into locking engagement with the blade-screw 51.

Now referring to FIG. 7 as well as FIGS. 8A and 8B, the persuader 80 maybe placed over and into engagement with the retractor 60. As best shownin FIG. 8B, the persuader 80 may include a body 81 having an innerperimeter 85 along a length thereof that circumscribes a correspondinglength of an outer perimeter 75 of the retractor 60. As shown, in somearrangements, the inner perimeter 85 of the persuader 80 and the outerperimeter 75 of the retractor 60 may have corresponding diameters inwhich the inner perimeter 85 is only slightly larger than the outerperimeter 75 such that the persuader 80 may slide over the retractor 60with the least amount of angulation or play allowable without forming aninterference fit with the retractor 60 that prevents removal of thepersuader 80 from the retractor 60. The body 81 of the persuader 80 mayinclude a viewing window 84, or, in some arrangements, a plurality ofviewing windows, defining a hole or a plurality of holes through athickness of the body 81. The window 84 may provide an area throughwhich to view the relative positions of the retractor 60 and thepersuader 80 during placement of the persuader 80, for example todetermine whether the fixation rod 5 has been fully persuaded.

In some arrangements, the body 81 may include a flange 86, which may behollow as shown in FIG. 7, extending at an oblique angle to alongitudinal axis defined by the inner perimeter 85 of the body 81. Insome arrangements as further shown in FIG. 7, a handle assembly 95 mayextend at an oblique angle to a longitudinal axis defined by the innerperimeter 85. The handle assembly 95 may include a handle 96, which mayinclude a friction-inducing grip for reducing slipping that mayotherwise be experienced by a user, that may extend from a connectingrod 97. As shown, the connecting rod 97 may be attached to the flange 86by a fastener, which may be inserted through a fastener inner perimeter87 defining a hole through the flange 86. In other arrangements, aconnecting rod of a handle assembly may form an interference fit with areceiving bore of a hollow flange extending from the body into which theconnecting rod may be inserted (not shown). In still other arrangements,a connecting rod of a handle assembly may form a monolithic structurewith a flange extending from the body.

With the persuader 80 placed over the retractor 60, the blocker inserterassembly 100 may be inserted along a longitudinal axis of a spacedefined by the single blade 52 of the blade-screw 51 and the retractor60. The blocker inserter assembly 100 may include a blocker inserter 101that may be temporarily engaged with a blocker 110, in which suchengagement may be through an interference fit between the blockerinserter 101 and the blocker 110. The blocker 110 may include externalthreads 111 that may engage corresponding threads 58 along a distalportion of the blade 52 and also threads 59 within the rod receivingsurface 55 in the head 53 of the blade-screw 51. The blocker 110 may berotated clockwise or counterclockwise by rotation of the blockerinserter 101 in a corresponding clockwise or counterclockwise directionto cause the blocker 110 to move distally or proximally, respectively.

The fixation rod 105 may be inserted within a working region defined bythe blade 52 of the blade-screw 51 and the second leg 66 of theretractor 60 and the receiving surface 55 of the head 53 of theblade-screw 51, which may be in the shape of a saddle (as best shown inFIG. 6B), facing inwardly in a proximal direction, in which thereceiving surface 55 may be U-shaped and the head 53 may be tulip-shapedas best shown in FIG. 3. In this configuration, the blocker 110 maycontact the fixation rod 105 to push or persuade the fixation rod 105distally towards the rod receiving surface 55 when the blocker 110 isturned in one direction and to allow the fixation rod to be raisedproximally when the blocker 110 is turned in the opposite direction.During the insertion of the blocker 110, in some arrangements, thepersuader 80 may confine the retractor 60 attached to the single blade52 to prevent the retractor legs 64, 66 from splitting apart, i.e.,separating in a direction away from each other. In this manner, thepersuader 80 may prevent the retractor 60 from disengaging theblade-screw 51 during either of insertion of the blocker 110 into theworking region described above or persuasion of the fixation rod 105. Insome arrangements, the persuader 80 may have a distal surface to exert aforce against the fixation rod 105 to cause the fixation rod 105 to movedistally. In still further arrangements, the persuader body 81optionally may have diametrically opposed recesses 83, as shown by thedashed lines in FIGS. 4 and 8A, at the distal end thereof for receivingthe rod 5 therein in a transverse orientation. In some sucharrangements, the fixation rod 105 may be pushed distally by thepersuader 80 to a position such that the threads 111 of the blocker 110may be engaged with either of the threads 58, 59 without contacting, andthus without interference caused by a proximal force due to, thefixation rod 105.

The persuader 80 may include one or more persuader holes 82 on a distalend of the persuader 80. When inserting the persuader 80 over theretractor 60, the body 81 of the persuader 80 may be positioned suchthat the persuader holes 82 and the holes 74 of the retractor 60 may bein alignment. In this manner, the persuader 80 may be placed in aposition relative to the retractor 60 in which the holes 82 of thepersuader 80 and the holes 74 of the retractor are placed in visualalignment. In some arrangements, this position may be located at aposition at which the persuader should not be pressed further along theretractor 60. In an alternative arrangement, the persuader may includeprotrusions in place of the holes 82 in which such protrusions may bedimensioned to be inserted into the holes 74 of the retractor 60 inorder to establish a desired relative alignment and position between thepersuader and the retractor.

In operation as illustrated in FIGS. 9 and 10, in accordance withanother embodiment, a qualified user, such as but not limited to aphysician, a surgeon, a physician's assistant, and a veterinarian, mayinsert a pedicle blade-screw 151 into a pedicle of a spine. As shown, ablade of the blade-screw 151 may have been broken off or otherwisedisconnected during insertion of the blade-screw 151 or during insertionof the fixation rod, while in rare instances, the blade-screw initiallymay have been produced with only a single blade. The user may place aretractor 160 over the pedicle blade-screw 151 such that the blade 152of the blade-screw 151 may be inserted into a groove 179 of theretractor 160. The retractor 160 may have first and second legs 164, 166extending from a body 165, the second leg 166 being on the same side asthe groove 179, in which prongs extending from the legs 164, 166 may beseparated a distance such that a first prong 168 and a second prong 169(not shown) snap into a groove on a head of the blade-screw 151. (SeeFIG. 6B for example).

If the blade were to be disconnected before the fixation rod wasinserted, the rod may be inserted using the retractor 160 as afunctional replacement for the blade-screw 151 having a missing blade.That is, the second leg 166 opposite the remaining blade 152 desirablyacts as a replacement for the missing blade by holding back thesurrounding tissue, such that the retractor 160 provides a pathwaythrough the tissue from the respective pedicle screw head to theincision through which the retractor 160 is disposed. Moreover, theslots 167 between the legs 164, 166 are analogous to the slots 67between the blades of the blade-screws 51 described previously herein,as the slots 167 of the retractor 160 allow the rod 5 to extendtransverse to the longitudinal axis of the retractor and be guidedtowards the pedicle screw heads.

After the fixation rod has been positioned within the body extendingbetween one or more blade screws 151 and/or retractors 160, the rod maythen be persuaded towards and into the rod receiving surfaces of thepedicle screw heads. Referring to FIG. 10, in some arrangements, a usermay grab either or both of a body 181 or a handle 196 of a handleassembly 195, in which the handle 196 as shown may extend at an anglefrom the body 181, to place and position a persuader 180 over theretractor 160. The persuader 180 may then be advanced distally such thatits distal end contacts the rod and persuades it towards the pediclescrew head, preferably at least until the rod is within the internallythreaded region of the retractor blade 152 analogous to the threads onthe blade 52 described previously herein. The persuader 180 desirablyoverlaps the first and second prongs 168, 169 of the retractor 160 tomaintain the prongs 168, 169 within the groove on the head of theblade-screw 151. Once the rod is positioned within the internallythreaded region of the retractor blade 152, the rod may be persuaded theremaining distance to the rod receiving surface of the pedicle screwhead by using the blocker inserter 201 having a blocker (not shown)positioned on its distal end. Specifically, the blocker inserter 201with blocker is inserted along the longitudinal axis of the retractor160, as shown in FIG. 10. The external threads of the blocker are thenengaged with the internal threads of the blade-screw 151, which may beon either or both of the blade 152 and the head of the blade-screw 151,and the blocker is advanced distally along the threads by rotating theblocker with the blocker inserter 201, thereby pushing the rod distallywith the distal end of the blocker. In some arrangements, the user maypush the persuader 180 against the fixation rod (see FIGS. 7 and 8A forexample) to persuade the fixation rod to cause the fixation rod to movedistally and to maintain separation between the fixation rod and theblocker during insertion of the blocker into the working region. In thismanner, the persuader may reduce or remove a proximal, oftenundesirable, force that may otherwise be exerted by the fixation rodagainst the blocker due to contact between the rod and the blockerduring insertion. Once the blocker is finally tightened within rodreceiving surface of the pedicle screw head, thus capturing and securingthe rod within the screw head, the blocker inserter 201 and persuader180 may be removed from the body. Thereafter, the retractor 160 may beremoved, in some arrangements by first applying an outward force on thearm (see FIGS. 6A and 6B for example) of the retractor 160 to disengagethe boss of the arm from the recess (see FIGS. 3 and 6B for example) inthe blade 152. Once the retractor 160 has been removed from the body,the remaining blade 152 may be broken off, such as by pivoting the blade152 about the frangible portion (see FIG. 3 for example) until thefrangible portion breaks. After all of the desired components have beenremoved from the body, the incisions through which the blade screws 151and other components of the blade rescue system extended may then beclosed.

In accordance with another embodiment of a blade rescue system, a bladerescue retractor 310, as illustrated in FIG. 11, may be used when bothblades have been disconnected from a pedicle screw head 300. Theretractor 310 may define a longitudinal pathway 311 therealong betweenits distal end 308 and its proximal end 309. The retractor 310 maycomprise a gripping member 312 and a locking member 314. In theembodiment of FIG. 11, both the gripping member 312 and the lockingmember 314 are hollow elongate bodies in which the gripping member 312is received within the locking member 314. In operation, the lockingmember 314 may be constructed to move in a proximal direction and adistal direction along the gripping member 312. The retractor 310desirably has an opening 313 into the longitudinal pathway 311 at itsproximal end 309, which opening 313 may be defined by an opening at theproximal end of the gripping member 312. FIG. 12 is an exploded view ofthe retractor 310, illustrating the locking member 314 separated fromthe gripping member 312 and also illustrating the actuation mechanism316 of the locking member 314 separated from the remainder of thelocking member 314.

The gripping member 312 is illustrated in FIG. 13, separated from thelocking member 314 of the retractor 310. The gripping member 312 has aproximal end 318 and a distal end 320. An interior surface 321 of thegripping member 312 preferably defines the longitudinal pathway 311along the retractor 310. In some embodiments, the interior surface 321may include a threaded portion (not shown), preferably at least near thedistal end 320 of the gripping member, for engagement with an externallythreaded blocker and advancement of that blocker towards and into thepedicle screw head 300, as discussed above in connection with theembodiments illustrated in FIGS. 8B and 10.

The gripping member 312 may have a generally tubular shape withdiametrically opposed slots 322 extending proximally from the distal end320 so as to define first and second legs 324, 326 extending distallyfrom a body portion 328. Such slots 322 desirably provide a spacethrough which a fixation rod may pass in an orientation transverse tothe longitudinal axis of the retractor 310, and, in some instances, theslots 322 may provide a viewing window between the legs 324, 326. Thegripping member 312 may be symmetrical on either side of the slots 322,such that the legs 324, 326 have the same structure. One or both legs324, 326 of the gripping member 312 may include a slot 332 extendingproximally from the distal end 320 so as to divide the distal portionsof the legs 324, 326 into a plurality of prongs 333. As shown in FIG.13A, which is a detail the slot 332 may have a distal end 334 open tothe distal end 320 of the gripping member 312 and a proximal end 336terminating at a hole 338. The hole 338 may be rounded to reduce stressconcentrations at the proximal end 336 of the slot 332, and, in someembodiments, the hole 338 may be circular. The slot 332 is preferablytapered such that it narrows towards its proximal end 336. However, inother embodiments, the slot 332 may have a substantially constant widthbetween its distal and proximal ends 334, 336. The gripping member 312is desirably at least partially flexible, such that the legs 324, 326can deflect at least slightly away from one another. The gripping member312 is also preferably sufficiently flexible to allow the prongs 333 tospread apart from one another.

The gripping member 312 may include an engagement portion 330 at itsdistal end 320 for engaging the pedicle screw head 300, as shown inFIGS. 17C and 17D. The engagement portion 330 may be in the form of acollar protruding radially outward from the outer surfaces of the legs324, 326. As shown in FIG. 13A, the proximal end of the engagementportion 330 may define a ledge 340 extending substantially transverse tothe longitudinal axis of the gripping member 312. The ledge 340 mayinclude one or more recesses 342 extending distally therefrom.

FIG. 13B illustrates a perspective view of the engagement portion 330showing the various structures for engaging the pedicle screw head 300.In particular, the engagement portion 330 preferably includes one ormore tabs 344 a,b projecting inwardly from an interior surface 346 ofthe engagement portion 330 and structured for engagement withcorresponding structures on the exterior surface 350 of the pediclescrew head 300. For example, tabs 344 a located on either side of theslots 322 between the legs 324, 326 may be sized to engage the pediclescrew head 300 along the edges 352 of the lateral openings 354 throughwhich the fixation rod passes when it is seated within the pedicle screwheads 300 (see FIG. 17D). The pedicle screw head 300 may includerecesses 348 a along those edges 352 for receiving the tabs 344 a of theengagement portion 330 (see FIG. 17D). Similarly, tabs 344 b located oneither side of the slots 332 of each leg 324, 326 may be sized to engageone or more recesses 348 b (see FIG. 17A) in the exterior surface 350 ofthe pedicle screw head 300 between the lateral openings 354.

Desirably, all of the tabs 344 a,b have an angled chamfer 356 on theirdistal ends to ease insertion of the gripping member 312 and, in turn,the retractor 310 over the pedicle screw head 300. For example, as shownin FIG. 14, the chamfers 356 may be arranged such that, as the distalend 308 of the retractor 310 is moved distally over the proximal end 358of the pedicle screw head 300, the chamfers 356 will cause theengagement portion 330 to spread apart. In particular, the chamfers 356on tabs 344 a will cause the prongs 333 to spread apart, and thechamfers 356 on tabs 344 b will cause the legs 324, 326 to spread apart,such that the pedicle screw head 300 is received within the engagementportion 330. Further distal movement of the retractor 310 will move thetabs 344 a,b into engagement with the corresponding recesses 348 a,b ofthe pedicle screw head 300. Once the tabs 344 a,b are seated within therecesses 348 a,b, the engagement portion 330 is preferably structured toat least somewhat resist unwanted separation of the retractor 310 fromthe pedicle screw head 300. That is, lateral surfaces 360 on theproximal ends of the tabs 344 a,b will engage lateral surfaces 362 atthe proximal ends of the recesses 348 a,b to prevent the retractor 310from moving proximally and disengaging the pedicle screw head 300.Additionally, lateral surfaces 364 at the proximal end of the engagementportion 330 will engage the proximal end 358 of the pedicle screw head300 to prevent the retractor 310 from moving distally with respect tothe pedicle screw head 300.

Referring again to FIG. 13, an exterior surface 365 of the grippingmember 312 between its proximal and distal ends 318, 320 may include oneor more projections 366 extending laterally outward. In someembodiments, such projections may be in the form of generallycylindrical pins. Additionally, the proximal end 318 of the grippingmember may include an externally threaded portion 368.

FIG. 15 illustrates a perspective view of a portion of the lockingmember 314, separated from the gripping member 312, and with theactuation mechanism 316 removed. The locking member 314 has a proximalend 370 and a distal end 372. The locking member 314 may have a hollow,sleeve-like shape constructed to receive the gripping member 312 withinits interior. The locking member 314 may have a generally tubular bodyportion 374 with first and second generally planar legs 376, 378extending distally from its distal end 379, the legs 376, 378 defining apass-through slot 380 between the legs 376, 378. In the embodimentillustrated in FIG. 15, the legs 374, 376 have exterior surfaces 382that are substantially flat, while the interior surfaces 384 aregenerally curved so as to substantially match the exterior surface 365of the gripping member 312. The locking member 314 may be symmetrical oneither side of the pass-through slot 380, such that the legs 376, 378have the same structure.

In some alternative embodiments, the entire locking member 314 may havea generally tubular shape similar to that of the gripping member 312illustrated in FIG. 13, such that the legs 374, 376 of the lockingmember 314 are generally arcuate segments. In yet other embodiments,rather than being generally planar or generally arcuate, the legs 374,376 may have a substantially smaller profile and may be in the form ofrods extending distally from the body portion 374.

The interior surface 384 of the locking member 314 may include at leastone or more projections 388 extending laterally inwardly, and preferablyincludes one such projection 388 located on each of the legs 376, 378.The projections 388 are preferably arranged to be received within thecorresponding slots 332 in the legs 324, 326 of the gripping member 324.Such projections may be in the form of generally cylindrical pins.Desirably, when the locking member 314 is moved in the proximaldirection, the projections 388 are shaped to cause the prongs 333 tospread apart as each projection 388 is moved proximally within thetapered slot 332.

The distal end 372 of the locking member 314 may include one or moredistally extending projections 386 configured to be received within thecorresponding recesses 342 in the engagement portion 330 of the grippingmember 312. When engaged with the corresponding recesses 342, theprojections 386 of the locking member may desirably restrain the prongs333 of the gripping member 312 from spreading apart.

The locking member 314 may include one or more slots 390 arranged toreceive the one or more projections 366 of the gripping member 312therein. Desirably, the interaction between the projections 366 and theslots 390 constrains the movement of the locking member 314 with respectto the gripping member 312 to be substantially linear along the proximaland distal directions, while preventing either the locking member 314 orthe gripping member 312 from rotating with respect to one another aboutthe longitudinal axis of the retractor 310.

The proximal end 392 of the body portion 374 may include a connection394 for engaging the actuation mechanism 316. The connection 394 mayinclude an annular recess 393 extending around the circumference of thebody portion 374 and an annular flange 395 positioned proximally of therecess 393. The annular flange 395 is preferably chamfered at itsproximal end 397 to ease the connection of the actuation mechanism 316to the body portion 374. The proximal end 370 of the locking member 314also preferably includes at least one slot 396 extending distally fromthe proximal end 392 of the body portion 374. The slot 396 may have aproximal end 398 open to the proximal end 392 of the body portion 374and a distal end 400 terminating at a hole 402. The hole may be roundedto reduce stress concentrations at the distal end 400 of the slot 396,and, desirably, the hole 402 may be circular. The slot 396 preferablyallows the proximal end 392 of the body portion 374, and thus theconnection 394, to deflect at least slightly inwardly so that theactuation mechanism 316 can be snapped on to the proximal end 392 of thebody portion 374 and into engagement with the connection 394.

As shown in FIGS. 16A and 16B, one embodiment of the actuation mechanism316 is in the form of a generally tubular sleeve. The actuationmechanism 316 has a distal end 404 and a proximal end 406. A connection408, which is structured to engage the connection 394 at the proximalend 392 of the body portion 374, may be located in the interior of theactuation mechanism 316 at its distal end 404. The connection 408 mayinclude an annular recess 410 extending around the circumference of thebody portion 374 and an annular flange 412 positioned distally of therecess 410. The annular flange 412 is preferably chamfered at its distalend 414 to ease the connection of the actuation mechanism 316 to thebody portion 374. The actuation mechanism 316 may thus be connected tothe body portion 374 by fitting the distal end 404 of the actuationmechanism 316 over the proximal end 392 of the body portion 374 untilthe annular flange 412 of the actuation mechanism 316 is received withinthe annular recess 393 of the body portion 374 and the annular flange395 of the body portion is received within the annular recess 410 of theactuation mechanism 316. That engagement desirably permits the actuationmechanism 316 to rotate with respect to the body portion 374 about thelongitudinal axis of the retractor 310 while restraining the actuationmechanism 316 from separating from the body portion 374.

The actuation mechanism 316 desirably includes an internally threadedportion 416 configured to engage the externally threaded portion 368 ofthe gripping member 312 when the gripping member is received within thelocking member 314. In that manner, rotation of the actuation mechanism316 with respect to the body portion 374 of the locking member 314 willcause the locking member 314 to move in a proximal direction or a distaldirection along the gripping member 312. That rotation is preferablydriven by a tool removably engaged to a tool interface 418 at theproximal end 406 of the actuation mechanism 316. As shown in FIG. 16A,the tool interface 418 may comprise an external, hexagonally shapedinterface configured to be received within a correspondingly shapedrecess of the tool or engaged by a wrench or other appropriate tool.Alternatively, any other configuration of a tool interface known in theart may be used.

The locking member 314, and preferably at least the legs 376, 378 of thelocking member 314, are desirably relatively rigid, while the grippingmember 312 is desirably partially flexible, such that the legs 324, 326and prongs 333 can spread apart from one another, as discussed above. Inthat manner, as discussed above, the flexibility of the legs 324, 326and prongs 333 may permit the engagement portion 330 to spread apartwhen moved distally over the proximal end 358 of the pedicle screw head300, after which the tabs 344 a,b of the engagement portion 330 maybecome engaged with the recesses 348 a,b of the pedicle screw head 300.Once the engagement portion 330 is engaged with pedicle screw head 300,the locking member 314 may help to rigidly secure the retractor 310 tothe pedicle screw head 300 by preventing the gripping member 312 frombecoming disengaged with the pedicle screw head 300. In particular, thelocking member 314 may be advanced distally along the gripping member312 from a retracted position towards a locked position, which causesthe legs 376, 378 of the locking member 314 to move distally along thelegs 324, 326 of the gripping member 312. In that manner, the relativelyrigid legs 376, 378 of the locking member 314 preferably restrain therelatively flexible legs 324, 326 of the gripping member 312 fromdeflecting outwardly and thereby disengaging the pedicle screw head 300.In a similar manner, the relatively rigid legs 376, 378 of the lockingmember 314 also preferably restrain the prongs 333 of the grippingmember 312 from spreading apart.

An exemplary method of using the blade rescue retractor 310 of FIGS.11-16B is illustrated in FIGS. 17A-D. As shown, the use of the retractor310 may be particularly desirable in cases where both blades of theblade screw have been removed and further access to the pedicle screwhead 300 is desired. Such scenarios may arise, for example, where bothblades of the blade-screw were intentionally or unintentionally removed(e.g., broken off at frangible portions) before it was determined thatfurther revision may be necessary.

In order to help move the retractor 310 into engagement with the pediclescrew head 300, an elongate guide tool 420 may first be inserted througha skin incision and distally into engagement with the pedicle screw head300. The guide tool 420 may include an engagement portion 422 at itsdistal end 423 for stable engagement with the pedicle screw head 300. Inthe embodiment illustrated in FIG. 17A, the engagement portion 422 maycomprise a slot 424 extending proximally from the distal end 423 of theguide tool 420. The slot 424 may have a distal end 426 open to thedistal end 423 of the guide tool 420 and a proximal end 428 terminatingat a hole 430. The hole may be rounded to reduce stress concentrationsat the proximal end 428 of the slot 424, and, desirably, the hole 430may be circular. The slot 424 may allow the engagement portion 422 todeflect at least slightly inwardly. The outer surface 431 of the guidetool 420 is preferably slightly larger than the interior dimension ofthe rod receiving surface 432 (see FIGS. 17C and 17D) in the pediclescrew head 300, such that the engagement portion 422 may deflectslightly inwardly upon being received within the rod receiving surface432, so as to stabilize the engagement between the engagement portion422 and the rod receiving surface 432. The engagement portion 422 mayalso include one or more laterally extending projections 434, which maybe sized to be received within the lateral openings 354 of the pediclescrew head 300, to further stabilize the engagement between theengagement portion 422 and the pedicle screw head 300. Desirably, theouter surface 431 of the guide tool 420 proximal of the engagementportion 422 is sized to be relatively closely received within theinterior surface 321 of the gripping member 312.

After the guide tool 420 is moved into engagement with the pedicle screwhead 300, the retractor 310 may be advanced distally along the guidetool 420 towards the pedicle screw head 300, preferably with the lockingmember 314 in a retracted position, as shown in FIG. 17A. The retractor310 may be advanced until the engagement portion 330 of the grippingmember 312 moves over and into engagement with the pedicle screw head300, after which the locking member 314 may be advanced distally fromthe retracted position (as shown in FIG. 17C) to a locked position (asshown in FIG. 17D), in order to restrain the engagement portion 330 ofthe gripping member 312 from spreading apart and becoming disengagedwith the pedicle screw head 300. In order to advance the locking memberdistally towards the locked position, a tool 436 may be engaged with thetool interface 418 at the proximal end 406 of the actuation mechanism316, as shown in FIG. 17B. The tool 436 may include a recess (not shown)at its distal end 438 for receiving the tool interface 418, and the tool436 may include a handle 440 at its proximal end 442 for providing agripping surface and also, preferably, leverage for rotating the tool436 to drive the actuation mechanism 316.

Once the retractor 310 is securely engaged to the pedicle screw head300, the retractor 310 may be used in much the same manner as theretractor 60 of FIGS. 4-8B. That is, if both blades were broken offbefore the fixation rod was inserted, the rod may be inserted using theretractor 310 as a functional replacement for the blade-screw having themissing blades. That is, the first and second legs 324, 326 of thegripping member 312, stabilized by the first and second legs 376, 378 ofthe locking member 314, desirably act as replacements for the missingblades by holding back the surrounding tissue, such that the retractor310 provides a pathway through the tissue from the respective pediclescrew head 300 to the incision associated with that pedicle screw.Moreover, the slots 322 between the legs 324, 326 of the gripping member312 are analogous to the openings between the blades of theblade-screws, as the slots 322 of the gripping member 312 allow thefixation rod to extend transverse to the longitudinal axis of theretractor 310 and be guided towards the pedicle screw heads 300.

After the fixation rod has been positioned within the body extendingbetween one or more blade screws and/or retractors 160 (as shown inFIGS. 4-8B) and/or retractors 310, the rod may then be persuaded towardsand into the rod receiving surfaces 432 of the pedicle screw heads 300.That may involve use of a persuader (not shown) in much the same manneras the persuader 80 illustrated in FIGS. 4 and 7-8B, which persuader maybe sized and shaped to be positioned over the retractor 310 and advanceddistally to persuade a transversely oriented rod towards the pediclescrew head 300. A blocker inserter with blocker may also be used andpositioned within the longitudinal pathway 311 of the retractor 310through the opening 313 at its proximal end 309. In embodiments of theretractor 310 having a threaded portion along a portion of the interiorsurface 321 of the gripping member 312, the blocker (not shown) may beengaged with the threads of such threaded portion and rotated to advancethe blocker along the threaded portion and into engagement with thethreads 444 (see FIG. 17D) in the rod receiving surface 432 of thepedicle screw head 300.

Once the blocker is finally tightened within rod receiving surface 432of the pedicle screw head 300, thus capturing and securing the rodwithin the screw head 300, the blocker inserter 201 and persuader 180may be removed from the body. Thereafter, the retractor 310 may beremoved. In order to remove the retractor 310, the locking member 314may first be moved proximally into the retracted position, such as byrotation of the actuation mechanism 316 with the tool 436. As discussedabove, the proximal movement of the locking member 314 may cause theprojections 388 of the locking member 314 to move proximally within thetapered slots 332 of the gripping member 312, thus spreading apart theprongs 333 of the gripping member 312. Even with the prongs 333 spreadapart, however, twisting of the retractor 310 about its longitudinalaxis may be necessary to cause the engagement portion 300 to furtherspread apart and disengage tabs the tabs 344 a,b from the recesses 348a,b in the pedicle screw head 300, so that the retractor 310 can beremoved. After all of the desired components have been removed from thebody, the incisions through which the blade screws, retractors 310, andother components of the blade rescue system extended may then be closed.

FIGS. 18 and 19 illustrate alternative embodiments of a gripping member312′ and a locking member 314′ (with actuation mechanism 316′), whichare largely similar to those illustrated in FIGS. 13 and 15,respectively, and in which like reference numerals refer to likeelements. Among the differences from the gripping member 312 of FIG. 13,the gripping member 312′ of FIG. 18 includes a threaded portion 500along its inner surface 321′ near the distal end 320′. The threadedportion 500 may be constructed for engagement with an externallythreaded blocker so as to advance that blocker towards and into thepedicle screw head, as discussed above in connection with theembodiments illustrated in FIGS. 8B and 10. Also in the embodiment ofFIG. 18, the holes 338′ at the proximal ends 336′ of the slots 332′ ineach of the legs 324′, 326′ have an elongated shape. In particular, theholes 338′ may have a generally elliptical shape having a major diameterextending substantially along the longitudinal axis of the grippingmember 312′. The projections 366′ along the exterior surface 365′ of thegripping member 312′ of the embodiment of FIG. 18 also may have anelongated shape. For example, the projections 366′ may be elongatedsubstantially along the longitudinal axis of the gripping member 312′.Among the differences from the locking member 314 of FIG. 15 are theshape of the projections 388′ extending inwardly from the interiorsurface 384′ for engagement with the slots 332′ of the gripping member312′. In particular, the projections 388′ may have an elongated shape(e.g., elongated substantially along the longitudinal axis of thelocking member 314′).

In an alternative embodiment of a locking member (not shown) for use ina blade rescue retractor like that illustrated in FIGS. 11-19, thelocking member need not extend substantially along the entire length ofthe gripping member in locked position. Such an embodiment of thelocking member may not include legs, and the tubular body portion mayinstead be structured to extend at least partially along the legs 324,326 of the gripping member 312 in the locked position, so as to restrainthe legs 324, 326 of the gripping member 312 from deflecting outwardlyand disengaging the pedicle screw head 300.

In a further alternative embodiment of a blade rescue retractor (notshown) like that illustrated in FIGS. 11-19, the locking member andgripping member may instead be structured so that the locking member isreceived within the gripping member. In such an embodiment, theengagement between the locking member and the gripping member may besuch that, when the locking member is in the locked position, thelocking member restrains the legs of the gripping member from deflectingoutwardly and disengaging the pedicle screw head 300. For example, thegripping member may include a structure such as an internal track forreceiving the legs, or some other engagement structure on the legs, ofthe locking member. In yet a further embodiment of a blade rescueretractor (not shown), the legs of the locking member may be structuredas stiffening members which are received within and movable alongchannels formed inside the legs (i.e., between the interior and exteriorsurfaces of the gripping member).

Although the blade rescue systems and methods of use above weredescribed in connection with integrated blade-screws in which one orboth blades had been broken off (e.g., broken at the frangibleportions), such blade rescue systems could also be used in connectionwith other types of percutaneous access devices (such as those describedin the '355 patent or the '798 patent) after such percutaneous accessdevices have been removed or have failed. For example, the blade rescueretractor 60 discussed in connection with FIGS. 4-8B could be used witha system having blades separately formed from and detachably connectableto the pedicle screw heads, as described in the '798 patent, and inwhich one of the blades has become disconnected to the associatedpedicle screw head. Similarly, the blade rescue retractor 310 discussedin connection with FIGS. 11-17D could also be used with a similar systemof separately formed blades in which both blades have becomedisconnected from the pedicle screw head.

In some alternative arrangements of any of at least the coupling, theretractor, the gripping member, the locking member, and the persuader asdescribed previously herein, where either or all of bosses, projections,and protuberances are described as interfacing with holes, slots, orrecesses, such holes, slots, or recesses and either or all of thebosses, projections, and protuberances corresponding to, being insertedin, or being engaged with the respective holes, slots, or recesses maybe reversed such that they are on the other feature than that previouslydescribed herein. In some arrangements, where either or both of bossesand protuberances are described as being from flexible tabs or arms,such bosses and protuberances may simply extend from a wall, an innerperimeter, or body that may be rigid or inflexible.

It is to be understood that the disclosure set forth herein includes allpossible combinations of the particular features described. For example,where a particular feature is disclosed in the context of a particularaspect, arrangement, configuration, or embodiment, or a particularclaim, that feature can also be used, to the extent possible, incombination with and/or in the context of other particular aspects,arrangements, configurations, and embodiments of the invention, and inthe invention generally.

Furthermore, although the invention herein has been described withreference to particular embodiments, it is to be understood that theseembodiments are merely illustrative of the principles and applicationsof the present invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

The invention claimed is:
 1. An access device for percutaneouslyaccessing a pedicle fastener connected to a vertebra of a patient, theaccess device comprising: an elongate gripping member including a bodyportion, a first leg, and a second leg, the first and second legs eachhaving a proximal portion connected to the body portion and a distalportion for engagement with a head of a pedicle fastener, the distalportion of the first leg including a first prong and a second prong, andthe distal portion of the second leg including a third prong and afourth prong, the first and second prongs having a first longitudinalslot therebetween permitting the first and second prongs to spread apartfrom one another, and the third and fourth prongs having a secondlongitudinal slot therebetween permitting the third and fourth prongs tospread apart from one another, wherein the distal portions of the firstand second legs are deflectable away from one another to engage anddisengage the head of the pedicle fastener, and wherein the first andsecond legs of the gripping member define a first pass-through slottherebetween, the first pass-through slot adapted to receive a spinalfusion rod therethrough; and an elongate locking member connected to andmovable relative to the gripping member between a retracted position anda locked position, wherein the locking member prevents the first andsecond legs of the gripping member from deflecting away from one anotherwhen in the locked position; wherein the access device includes at leastone projection arranged within the first slot, and wherein theprojection is adapted to move along the first slot to cause the firstand second prongs to spread apart from one another.
 2. The access deviceof claim 1, wherein the projection is connected to the locking member,and wherein movement of the locking member to the retracted positioncauses the projection to move along the first slot so as to deflect thefirst and second prongs away from one another.
 3. The access device ofclaim 1, further comprising at least one tab arranged to be receivedwithin a recess in the gripping member, wherein movement of the lockingmember to the locked position causes the tab to move into the recess. 4.The access device of claim 3, wherein the elongate locking member has afirst extension aligned along the first leg and a second extensionaligned along the second leg, and wherein the first and secondextensions of the locking member prevent the respective first and secondlegs of the gripping member from deflecting away from one another whenin the locked position, and wherein the tab is located at a distal endof the first extension.
 5. The access device of claim 4, wherein the tabextends in a distal direction from the distal end of the firstextension.
 6. The access device of claim 5, wherein the recess extendsdistally within a ledge, the ledge protruding outwardly from an outersurface of the first leg.
 7. The access device of claim 3, whereinengagement of the tab within the recess restrains movement of the firstand second prongs away from one another.
 8. The access device of claim7, wherein the recess is located on one of the first and second prongs.9. The access device of claim 1, wherein the gripping member is receivedwithin the locking member.
 10. The access device of claim 9, wherein thegripping member has a tubular shape defining a longitudinal pathwaytherein along a central longitudinal axis of the access device.
 11. Theaccess device of claim 1, wherein the locking member is movable along acentral longitudinal axis of the access device relative to the grippingmember between the retracted and locked positions.
 12. The access deviceof claim 11, further comprising an actuation mechanism for actuatingmovement of the locking member relative to the gripping member along thecentral longitudinal axis between the retracted and locked positions,wherein the actuation mechanism is adapted to actuate the movement ofthe locking member relative to the gripping member in response torotation of the actuation mechanism.
 13. The access device of claim 12,wherein the rotation of the actuation mechanism is about the centrallongitudinal axis of the access device.
 14. The access device of claim12, wherein the rotation of the actuation mechanism is along a threadedconnection.
 15. The access device of claim 1, wherein the elongatelocking member has a first extension aligned along the first leg and asecond extension aligned along the second leg, and wherein the first andsecond extensions of the locking member prevent the respective first andsecond legs of the gripping member from deflecting away from one anotherwhen in the locked position.
 16. The access device of claim 15, whereinthe first and second extensions of the locking member define a secondpass-through slot therebetween, the second pass-through slot adapted toreceive the spinal fusion rod therethrough, and wherein the first andsecond pass-through slots are aligned with one another about a centrallongitudinal axis of the access device.
 17. A percutaneous spinal fusionsystem comprising: the access device of claim 1; and the pediclefastener, wherein the pedicle fastener includes a first blade and asecond blade detachably connected thereto, the first and second bladeseach having a plurality of holes spaced apart along a length of therespective blades.
 18. A system for percutaneously accessing a pediclefastener connected to a vertebra of a patient, the pedicle fastenerhaving a head defining a receptacle for receiving a spinal fixation rodtherein, and the pedicle fastener having two blades detachably connectedto the head, comprising: the access device of claim 1, for use when bothof the blades become detached from the head; and a second access devicefor use when one of the blades becomes detached from the head, leaving aremaining blade, the second access device including an elongate bodyhaving a distal end for engagement with the head of the pediclefastener, the body defining a longitudinal bore therein along a centrallongitudinal axis of the body, and the body including a groove thereinextending longitudinally along the bore, the groove dimensioned toreceive the remaining blade of the pedicle fastener therein.
 19. Anaccess device for percutaneously accessing a pedicle fastener connectedto a vertebra of a patient, the access device comprising: an elongategripping member including a body portion, a first leg, and a second leg,the first and second legs each having a proximal portion connected tothe body portion and a distal portion for engagement with a head of apedicle fastener, the distal portion of the first leg including a firstprong and a second prong, and the distal portion of the second legincluding a third prong and a fourth prong, the first and second prongshaving a first longitudinal slot therebetween permitting the first andsecond prongs to deflect relative to each other, and the third andfourth prongs having a second longitudinal slot therebetween permittingthe third and fourth prongs to deflect relative to each other, whereinthe distal portions of the first and second legs are deflectable awayfrom one another to engage and disengage the head of the pediclefastener; and an elongate locking member connected to and movablerelative to the gripping member between a retracted position and alocked position, wherein the locking member prevents the first andsecond legs of the gripping member from deflecting away from one anotherwhen in the locked position, the locking member having a projectionconnected thereto, the projection being arranged within the first slot,wherein movement of the locking member to the retracted position causesthe projection to move along the first slot so as to deflect the firstand second prongs away from one another.
 20. The access device of claim19, further comprising at least one tab arranged to be received within arecess in the gripping member, wherein movement of the locking member tothe locked position causes the tab to move into the recess.
 21. Theaccess device of claim 20, wherein engagement of the tab within therecess restrains movement of the first and second prongs away from oneanother.
 22. The access device of claim 19, wherein the elongate lockingmember has a first extension aligned along the first leg and a secondextension aligned along the second leg, and wherein the first and secondextensions of the locking member prevent the respective first and secondlegs of the gripping member from deflecting away from one another whenin the locked position.
 23. A percutaneous spinal fusion systemcomprising: the access device of claim 19; and the pedicle fastener,wherein the pedicle fastener includes a first blade and a second bladedetachably connected thereto, the first and second blades each having aplurality of holes spaced apart along a length of the respective blades.